EUCTR2022-002431-53-FR进行中（未招募）1 期
A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER - DARIUS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Age = 18,
- •2.Histological diagnosis of prostate malignancy
- •3.Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional assessment by PET-Scan is allowed as per investigator judgement),
- •4.Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.
- •One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:
- •-Gleason = 7 (4+3)
- •-= 50% of thecore of biopsies need to be positive for adenocarcinoma
- •If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer:
- •-PSA value between 10-20 ng/ml
- •-Gleason 7 (3+4) or 6
- •-T2b (clinical or radiological)
- •Note: patients with iT3a (extraprostatic extension) can be included only if gleason score is 6 and PSA less than 20 [22].
- •5.Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration
- •6.Patients must have a life expectancy of at least 5 years,
- •7.Performance status ECOG = 2,
- •8.Patients without contra-indications to EBRT as per physician judgement,
- •9.Patients with adequate organ function defined by all the following laboratory values (< ULN (Upper Limit of Normal)) :
- •a)Hemoglobin = 9 g/dL,
- •b)Neutrophils = 1.5 G/L
- •c)Platelets = 80 G/L
- •d)Total bilirubin < 2X ULN
- •e)AST (SGOT) and ALT (SGPT) = 2.5 X ULN
- •f)Calculated creatinine clearance (CrCl) = 30 ml/min (according to Cockroft and Gault formula).
- •10.Available archived paraffin-embedded tumor sample for research purpose,
- •11.Patients with a social security in compliance with the french law,
- •12.Voluntary signed and dated written informed consent prior to any study specific procedure,
- •13.Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1.Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,
- •2.Patients with Gleason score =8,
- •3.Patients with PSA > 20 ng/ml,
- •4.Presence of loco-regional or distant metastasis (MRI/CT-Scan and Bone Scintigraphy),
- •5.Contra-indications to MRI and to contrast-enhanced CT-scan,
- •6.Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution.
- •7.Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy,
- •8.Patients with previous orchiectomy
- •9.Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents,
- •10.Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,
- •11.Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,
- •12.Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),
- •13.History of cerebrovascular accident (within the last 6 months)
- •14.Impaired cardiac function including any one of the following:
- •a)Clinically documented myocardial infarction (within the last 6 months)
- •b)History of severe/unstable angina (within the last 6 months)
- •c)History of peripheral artery/coronary bypass surgery (within the last 6 months)
- •d)History of or presence of congestive heart failure according to the New York Heart Association (NYHA) class 3 or 4 with LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram or multi-gated acquisition scan performed in the last 6 months
- •e)History of or prensece of risk factors for QT interval prolongation
- •f)History of or presence of clinically significant ventricular or atrial tachy-arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- •g)Clinically significant resting bradycardia (< 50 beats per minute)
- •h)History of Mobitz II second degree or third degree heart block without use of ventricular-paced pacemaker
- •i)History of or presence of clinically significant hypotension (e.g. systolic blood pressure < 86 mmHg on 2 consecutive measurements)
- •j)ECG demonstrating equal to or greater than grade III toxicity according the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- •15. Uncontrolled hypertension
- •16.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery),
- •17.Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection (extended or limited),
- •18.Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone (GnRH) or its analogues
- •19.Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome
- •20.Men who are not using an effective method of contraception as previously described
- •21.Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,
- •22.History of non-compliance to medical regimens or i
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